The following data is part of a premarket notification filed by Bdm Medical, Inc. with the FDA for Spider Strap.
Device ID | K963138 |
510k Number | K963138 |
Device Name: | SPIDER STRAP |
Classification | Restraint, Protective |
Applicant | BDM MEDICAL, INC. 518 MAIN ST. P.O. BOX 515 Ashton, ID 83420 |
Contact | Bonnie J Burlage |
Correspondent | Bonnie J Burlage BDM MEDICAL, INC. 518 MAIN ST. P.O. BOX 515 Ashton, ID 83420 |
Product Code | FMQ |
CFR Regulation Number | 880.6760 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1996-08-13 |
Decision Date | 1996-11-06 |